Trial of PI-88 With Docetaxel in Advanced Non-Small-Cell Lung Cancer (NSCLC)

NCT ID: NCT00097851

Last Updated: 2022-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2006-07-31

Brief Summary

PI-88 is a new experimental drug that inhibits tumour growth by reducing the formation of new blood vessels into tumours. Docetaxel is a standard second-line treatment offered to patients with non-small-cell lung cancer who haven't responded to first-line therapies (platinum-based drugs or radiotherapy). Of this group of patients, only 20% remain progression-free 6 months after starting docetaxel treatment. The PR88202 study has been designed to compare two different cancer treatments (docetaxel only, and docetaxel plus PI-88) and to work out which is more effective against the cancer. It is hoped that the combination of PI-88 with docetaxel will allow patients to extend the time it takes for their disease to progress, and also to improve their quality of life.

Detailed Description

PR88202 is an open-label randomized study. In the initial phase of the study, patients will be randomized to receive weekly docetaxel alone, or PI-88 in combination with weekly docetaxel. Both groups will receive docetaxel (30 mg/m2), administered by intravenous infusion on days 1, 8 and 15 of a 28-day cycle. The second group only will receive PI-88 (250 mg/day) in addition to docetaxel; PI-88 will be administered by subcutaneous injection on days 1-4, 8-11 and 15-18 of each cycle. The primary efficacy endpoint is the non-progression rate at 6 months. In the extension phase of the study, patients in the combination arm who have stable disease or an objective response after up to six treatment cycles will remain on PI-88 alone as maintenance therapy. Patients who initially receive docetaxel alone and who have disease progression or unacceptable toxicity before the completion of six cycles will be eligible to receive PI-88 alone as third-line therapy.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

docetaxel

Intervention Type: DRUG

PI-88

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• histologically or cytologically confirmed stage IIIb or IV NSCLC that has progressed during or after first-line treatment
• measurable disease by spiral CT chest scan, as defined in RECIST criteria
• performance status 0-1 (ECOG)
• life expectancy at least 2 months
• adequate hemopoietic, renal and hepatic function

Exclusion Criteria

• current symptomatic central nervous system (CNS) involvement
• prior or co-existent malignancies
• significant non-malignant disease
• acute or chronic gastrointestinal (GI) bleeding in last two years
• inflammatory bowel disease
• abnormal bleeding tendency
• patients at risk of bleeding due to open wounds or planned surgery
• clinically significant hemoptysis within the past 4 weeks
• bilirubin > upper limit of normal (ULN)
• ALT and AST > 2.5 times ULN, or > 1.5 times ULN if alkaline phosphatase > 2.5 times ULN
• alkaline phosphatase > 5 times ULN, unless patient has bone metastases
• myocardial infarction, stroke or congestive heart failure within last 3 months
• prior treatment with docetaxel
• concomitant treatment with aspirin (>100 mg/day), NSAIDs (except selective COX-2 inhibitors, warfarin (>1 mg/day), heparin, LMWH, anti-platelet drugs, CYP3A4 inhibitors
• women who are pregnant or breast-feeding
• women of child-bearing potential not using adequate contraception
• history of allergy and/or hypersensitivity to anti-coagulants or thrombolytic agents, especially heparin
• history of immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura or other platelet disease
• allergy to polysorbate 80 (component of Taxotere®)
• uncontrolled or serious infection in last 4 weeks

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medigen Biotechnology Corporation

INDUSTRY

Sponsor Role: collaborator

Cellxpert Biotechnology Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nick Pavlakis, MD

Role: STUDY_CHAIR

Royal North Shore Hospital

Paul Mitchell, MD

Role: STUDY_DIRECTOR

Austin and Repatriation Hospital

Locations

Sydney Cancer Centre, Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Sydney Haematology and Oncology Clinics

Hornsby, New South Wales, Australia

Prince of Wales Hospital

Randwick, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Newcastle Mater Misericordiae Hospital

Waratah, New South Wales, Australia

Prince Charles Hospital

Chermside, Queensland, Australia

Nambour General Hospital

Nambour, Queensland, Australia

Mater Hospital

South Brisbane, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

The Queen Elizabeth Hospital

Woodville, South Australia, Australia

The Alfred Hospital

Prahran, Victoria, Australia

Border Medical Oncology

Wodonga, Victoria, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Countries

Australia

Other Identifiers

PR88202

Identifier Type: -

Identifier Source: org_study_id